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Monday, October 10, 2022

Mr. Paul Goes to Washington

 For all its virtues, Mr. Smith Goes to Washington has never been considered a realistic film. Critics complain that Frank Capra’s movie is at once too corny and too cynical: one brave senator singlehandedly defending the public good against the thoroughly corrupt political and journalistic establishments. But we’ve been seeing a version of that plot for two years now, thanks to Senator Rand Paul’s lonely battle against Anthony Fauci, the Centers for Disease Control, and the mainstream press.

Like the politicians meekly following orders in the film, most of Washington has bowed to the CDC’s Covid edicts, but Paul has never tired of challenging the agency’s futile policies and dubious science. Like the movie’s media baron Jim Taylor, Fauci’s cheerleaders in the press and on social-media platforms have shamelessly pushed the party line—and worked hard to squelch opposing views, though they prefer to use “fact-checkers” rather than the street thugs whom Taylor hired to silence a rival newspaper. Journalists have smeared Paul, and censors have removed some of his scientifically accurate heresies from YouTube, but no one can stop him from regularly berating Fauci at the televised hearings of the Senate health committee.

Paul isn’t as folksy or likable as Jeff Smith (Jimmy Stewart), and his tousled hair isn’t quite as disheveled as during Smith’s epic filibuster, but he, too, likes to deliver lectures on democracy and liberty. Unlike Smith, he hasn’t read the Declaration of Independence to his jaded colleagues—at least, not yet—but he did invoke Friedrich Hayek’s The Fatal Conceit at a hearing early in the pandemic, when he was pleading with Fauci to stop locking down Americans in their homes.

“The fatal conceit is the concept that central planning, with decision-making concentrated in a few hands, can never fully grasp the millions of complex individual interactions occurring simultaneously in the marketplace,” Paul told Fauci. “Only decentralized power and decision-making based on millions of individualized situations can arrive at what risks and behaviors each individual should choose. That’s what America was founded on, not a herd with a couple of people in Washington telling us what to do and we like sheep blindly follow.”

Paul sounded this theme throughout the pandemic, denouncing Fauci as a “petty tyrant” and “dictator in chief” who needlessly stoked fear to create a “nanny state” and “corral our freedom.” In the spring of 2020, when Fauci referred to the lockdowns as merely “inconvenient,” Paul lambasted him for ignoring the vast economic and social damage, and presciently warned, “Our reaction to the virus may turn out to be worse than the virus itself.”

At a hearing that summer, Paul summarized evidence from the U.S., Europe, and China that it was safe to open schools, and showed it to Fauci, with charts mounted on easels. “When are we going to tell people the truth—that it’s okay to take their kids back to school?” he asked. He couldn’t get a straight answer. While schools safely opened across Europe that fall, Fauci and the CDC kept finding reasons to keep American students out of the classroom (and placate teachers’ unions).

Over and over, at Senate hearings and in a stream of op-eds, Paul has offered more sensible policy prescriptions and better scientific guidance than Fauci, the CDC, or the media. While the Washington establishment relentlessly pushed mask mandates, Paul presented some of the abundant evidence that cloth and surgical masks were ineffective, telling Fauci, “You parade around in two masks for show.” While journalists and social-media platforms dismissed and censored suggestions that Covid had leaked out of a lab in Wuhan, Paul called out Fauci for working to suppress that legitimate discussion. He also showed that Fauci had been hiding his agency’s role in funding risky “gain-of-function” viral research at that lab. After Fauci denied that the National Institutes of Health had ever funded such research, Paul recited the damning evidence that it had done just that.

When Fauci plotted with Francis Collins, the NIH head, to plant “takedown” stories in the media depicting the authors of the Great Barrington Declaration as “fringe” scientists for daring to oppose lockdowns, journalists obediently went along with the campaign against these researchers from Oxford, Harvard, and Stanford. When Fauci declared that “attacks on me quite frankly are attacks on science,” journalists kept fawning—but Paul went after him.

“A planner who believes he is ‘the science,’ leads to an arrogance that justifies, in his mind, using government resources to smear and to destroy the reputations of other scientists who disagree with him,” Paul told Fauci at hearing in January. “This is not only antithetical to the scientific method, it’s cheap politics, and it’s reprehensible, Dr. Fauci. Do you really think it’s appropriate to use your $420,000 salary to attack scientists that disagree with you?” Fauci dodged that question, as he routinely does during his confrontations with Paul. He’s a master of changing the subject, and the Democrats running the hearings make sure to limit Paul’s interrogations and give Fauci the last word.

But Paul has managed to pin Fauci down during their debates over America’s vaccine policies. Many other countries exempted people from vaccination requirements if they’d already been infected with Covid, and the European Union made them eligible for vaccine passports. But the U.S. made no such allowances, resulting in people losing their jobs and being barred from schools and other public places despite having natural immunity.

The U.S. has also been an outlier in pushing vaccines on kids. The European Union, unlike the U.S., has not yet approved Covid vaccines for children under five. Except for Austria, European countries have not followed the U.S. in recommending a booster shot for healthy children under 12, and most don’t recommend it for healthy adolescents, either. Some countries have decided to stop even offering vaccines or boosters to young people outside the high-risk groups: the United Kingdom’s exclusion applies to children under 11, while Sweden’s extends up to age 18, and Denmark’s goes all the way up to age 50.

Young people have never been at serious risk from Covid, and now that most of them have natural immunity, there’s less reason than ever for them to get vaccines with rare but serious side effects. Those side effects led Florida’s surgeon general, Joseph Ladapo, to recommend against vaccinating healthy children under 18, and on Friday he went further. Citing new evidence in Florida of an increased rate of cardiac-related mortality among young men shortly after receiving the Pfizer or Moderna vaccine, he recommended against these mRNA vaccines for men between 18 and 39.

But Fauci and the CDC have kept urging that every American over six months old get vaccinated, and that everyone over five get an additional booster. While the press flacked for the administration’s policies—CNN enlisted Sesame Street’s Big Bird to entice toddlers to be jabbed—Paul performed the cost–benefit analysis shirked by Fauci and his journalist fan club. At a June hearing, Paul reminded Fauci of CDC data, initially hidden by the agency, showing that a booster shot did not reduce the rate of Covid hospitalization or death among adults between 18 and 49.

“Are you aware of any studies,” he asked Fauci, “that show reduction in hospitalization or death for children who take a booster?”

“Right now there’s not enough data that has been accumulated to indicate that that’s the case,” Fauci replied. Under Paul’s questioning, Fauci further conceded that the CDC had not even studied whether vaccination reduced the risk of serious disease in children with natural immunity—which includes practically all children, because the CDC’s seroprevalence surveys show that 86 percent of Americans under 18 have had a Covid infection. So, Paul continued, while there was no proof these children would benefit from the vaccine, the administration was urging them to get shots that had been repeatedly shown to increase the risk of myocarditis in young people.

“There are risks, and you’re telling everybody in America to blindly go out” and get vaccinated, Paul said. “That’s not science. That’s conjecture, and we should not be making public policy on it.”

Fauci refused to back down that day, insisting that vaccination could benefit even children with natural immunity, but he had a more awkward time of it during their next confrontation, at a hearing in September. Paul began his interrogation by playing a video of Fauci on C-SPAN in 2004 answering questions about the flu vaccine. If a woman had already had the flu that year, he was asked, should she still get a flu shot? “She definitely doesn’t need a flu vaccine,” Fauci replied. “The most potent vaccination is getting infected yourself.”

After the video ended, Paul reminded Fauci that most American children had already had Covid. “Yet there are no guidelines coming from you or anybody in the government to take into account their naturally acquired immunity,” Paul said. “We wonder why you seemed to really embrace basic immunology back in 2004 and why you seem to reject it now.”

“That film that you showed is really taken out of context,” Fauci said, launching into a defense of the Covid vaccine, but Paul cut him off with another theatrical maneuver.

“Actually, words don’t lie,” Paul said, pointing to an easel with Fauci’s 2004 quotation displayed in large type, and contrasting those words with the current policy of foisting two shots plus a booster on children with natural immunity. “You decry vaccine hesitancy—it’s coming from the gobbledygook that you give us,” Paul said. “The very basic science is that previous infection provides a level of immunity. If you ignore that in your studies, if you don’t present that in your committees, you’re not being truthful or honest with us.”

In a Frank Capra movie about Covid, that could have been the final scene. Like Smith’s foe, the smooth-talking, silver-haired senator played by Claude Rains, Fauci would have broken down and confessed his errors, and the press corps would have finally turned on him. Of course, that’s not what happened. Fact-checkers ruled that attempts to compare Fauci’s 2004 comments with current vaccine policy were “misleading” or “missing context,” because the flu was different from Covid, and journalists went on ignoring the question that they should have been asking: Why is America pressuring children with natural immunity to get so many shots of a vaccine with known risks and no proven benefit?

The closest thing to a happy plot twist in this saga is that Fauci, like Claude Rains’s senator, will be leaving his job, though not in disgrace but with an annual pension of more than $400,000. The announcement of his retirement inspired a flurry of media puff pieces hailing his public service, with scant mention of all the evidence that the lockdowns and other mandates were catastrophic mistakes. If you believed the Washington Post’s valedictory tribute, Fauci’s worst mistake in the pandemic was not insisting earlier on universal mask-wearing.

The journal Science saluted his retirement with a long interview mixing adulation (“You’ve never been much motivated by money”) with softball questions (“Is some of the vitriol toward you about being a flip-flopper with your pandemic advice a result of having to make public health decisions in public in real time?”). The only awkward moment came when the interviewer brought up Paul’s interrogations (“Why does that guy piss you off so much?”) and suggested ever so gently that Fauci should have admitted to Paul that his agency had indeed funded gain-of-function research at the Wuhan lab.

“You’re absolutely right,” Fauci said. “If I had to do it over again, I would have done it a little differently.” But, as usual, he knew it wasn’t his fault. The problem, he explained, was that Paul’s belligerence had so stunned him that he’d lashed out instead of remaining calm. “I just should have dropped back off and said, this guy’s a jerk.”

Fortunately, Paul aims to be even more of a jerk in the future. If Republicans regain a majority in the Senate this election, Paul stands to become chairman of the health committee, and he has promised to subpoena Fauci’s records and bring Fauci out of retirement to answer more questions. It won’t be easy holding the public health bureaucracy accountable for the unprecedented damage it has wrought, but thanks to Rand Paul, this movie isn’t over yet.

Applied DNA Gets Largest Single Purchase Order for LinearDNA™ To-Date

 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based DNA technologies, announced today that it received its largest single purchase order for LinearDNA™ valued above the mid-six-figures. The order was placed under a long-standing supply agreement for the bulk manufacture of LinearDNA for a global manufacturer of in vitro diagnostics. Under the terms of the repeat order, the Company will deliver quantities of LinearDNA to the customer in the current quarter, with the full order expected to be fulfilled over the subsequent three quarters.

LinearDNA is produced using an enzymatic (cell-free) manufacturing platform that eliminates the use of fermenters and bacteria required by plasmid DNA, the industry’s current manufacturing standard for DNA. LinearDNA eliminates many of the challenges associated with current plasmid-based DNA manufacturing and produces a DNA product without the risks of bacterial contamination and non-target DNA sequences. The enzymatic process provides the means to optimize a customer-specific chemistry and sequence of LinearDNA. This capability has been leveraged for diagnostic applications, including today's announced repeat order, and is commonly used when customers order LinearDNA for use as IVT templates for RNA production.

https://finance.yahoo.com/news/applied-dna-announces-receipt-largest-134500353.html

Boston wastewater covid virus levels rising

 Boston health officials are urging residents to vaccinate, test, and mask indoors as the concentration of COVID-19 in local wastewater continues to rise.

As of Monday, the amount of virus in local wastewater had increased 3.1% over the past seven days and 99.9% over two weeks, the Boston Public Health Commission said in a Friday release. 

“The elevated concentration of COVID-19 in our wastewater is very concerning,” Dr. Bisola Ojikutu, commissioner of public health and executive director of the Boston Public Health Commission, said in a statement. 

Wastewater monitoring can be an early indicator of COVID-19’s spread, according to the Centers for Disease Control and Prevention. Data from the Massachusetts Water Resources Authority — which tracks eastern Massachusetts wastewater at the Deer Island Treatment Plant — shows virus levels fluctuating following a steep spike that began in late September.

However, those numbers were still far lower than during the omicron surge at the start of this year. 

What are the latest numbers?

New COVID-19 cases in Boston decreased by 0.5% in the week leading up to Oct. 3, but were up 1.1% over two weeks, according to BPHC. That data does not include results from at-home tests, an increasingly popular testing option. 

Boston hospitals, meanwhile, had 170 new COVID-19-related hospital admissions this week. While the city’s hospitalization rate was stable over the past seven days, it represents a 13.7% increase over two weeks, BPHC noted. 

“Combined with flu season, increases in COVID-19-related hospitalizations will cause major strain on Boston’s health care system,” Ojikutu said. “It’s important we get ahead of this by getting boosted, obtaining a flu shot, wearing masks indoors, testing for COVID, and isolating if positive to help reduce transmission.”  

What can you do?

The commission is working with Boston hospitals and provider networks to ensure they are prepared for a scenario like the one Ojikutu described, according to its release. 

“Improving uptake of the new bivalent COVID-19 boosters, which provide the broadest protection and immunity against the original COVID-19 strain and the omicron variant, is critical to this goal,” BPHC said. 

The commission administered 783 COVID-19 vaccine doses last Saturday during a free vaccination clinic at White Stadium in Franklin Park. Today, 78.7% of Boston residents are fully vaccinated, according to BPHC. 

BPHC also advises other precautions, including testing before and after large gatherings, wearing masks indoors — especially in crowded places — and opting for outdoor activities as often as possible.

https://www.boston.com/news/coronavirus/2022/10/07/boston-health-boosters-tests-masks-covid-wastewater/

Satsuma upped to Outperform from Market Perform by Leerink

 Target $15

https://finviz.com/quote.ashx?t=STSA&p=d

SOBRsafe Expands to New York Metro Market via New Distributor with Ties to Air, Rail and Shipping

  SOBR Safe, Inc. (NASDAQ:SOBR) (SOBRsafe™ or the Company), providers of industry-leading alcohol screening solutions, today announced that leading New York Metro-based substance compliance provider ABW Compliance Services (ABW) has launched its touch-based alcohol screening offering with an initial multi-unit purchase of the SOBRcheck™ solution. ABW's customers include top brands in air and train travel, as well as global shipping.

SOBRsafe has engaged ABW specifically to help eliminate potential catastrophes, as when reported in March 2022 that a commercial pilot was removed from the cockpit and taken into custody after having a blood-alcohol level more than four times the federal limit. Consistent with its current deployment for commercial drivers, SOBRcheck could verify the sobriety of all groundcrew and on-plane personnel as they report for duty - instantaneously and with no invasive, unhygienic tests.

https://finance.yahoo.com/news/sobrsafe-expands-york-metro-market-120000543.html

Immatics: Clinical validation of PRAME as multi-tumor target

 Company to host conference call today, October 10, at 8:30 am EDT / 2:30 pm CEST

  • Clinical validation of PRAME as multi-tumor target with large potential for TCR-based therapies: confirmed responses in different solid cancers, in patients with high and low PRAME expression

  • Update covers data from 27 patients in completed Phase 1a dose escalation and first 5 patients in Phase 1b dose expansion (cohort A) treated with IMA203 monotherapy

  • Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5) in Phase 1b patients alone with all responses ongoing at data cut-off

  • Confirmed responses across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma

  • Treatment with IMA203 continues to show manageable tolerability; biological data including T cell engraftment, persistence and tumor infiltration consistent with clinical data

  • IMA203 TCR-T is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME; next data read-outs on IMA203 monotherapy, IMA203 in combination with a checkpoint inhibitor and 2nd generation IMA203CD8 planned during 2023

Immatics will host a conference call today, October 10, 2022, at 8:30 am EDT / 2:30 pm CEST to discuss these clinical data. The webcast and presentation can be accessed directly through this link. Participants may also access the slides and the webcast on the Immatics website in the Investors section under “Presentations” at www.investors.immatics.com/events-presentations. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Company’s website for at least 90 days.

Iradimed Withdraws 510(k) with Plans to Resubmit After Further Discussions with FDA

  IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump.

Roger Susi, President and Chief Executive Officer of the Company, commented, “We have been engaged in several productive and positive discussions with the FDA. The FDA requested additional information that was not feasible to provide within FDA’s review deadline; therefore, we decided to withdraw our application to provide us more time to understand and resolve the FDA’s concerns. We are confident that after working with the FDA, we will be able to submit a 510(k) application that leads to a timely clearance for the MRidium 3870 Infusion Pump System. It is important to note that this withdrawn 510(k) is for a future product and in no way affects our current revenue-generating product portfolio.”

The Company also announced selected preliminary financial results for the third quarter ended September 30, 2022. Third-quarter revenue is expected to be approximately $13.4 million, up 23% from the prior year and above the Company’s third-quarter guidance of $13.1 million - $13.3 million.

“These third quarter preliminary results represent our highest revenue quarter. It also continues a four-quarter trend of record revenues. Orders booked in the quarter exceeded our shipments as we continue to add to our extensive backlog. Domestic unit orders booked in the quarter for our current MRidium 3860 Infusion Pump System were the highest over the last three years, demonstrating the continued strong demand for this product,” said Roger Susi. “As we enter the remainder of 2022 and onward into 2023, we are positioned to continue to achieve our growth objectives with our current products,” Mr. Susi added.

https://finance.yahoo.com/news/iradimed-corporation-withdraws-510-k-120000972.html